NCT02319980

The Adult Hemorrhagic Moyamoya Surgery Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Detailed description

About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus. The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain. Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.

Conditions

• Moyamoya
• Stroke

Interventions

Type	Name	Description
PROCEDURE	Extracranial-intracranial bypass surgery	All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS)

Timeline

• Start date: 2015-05-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2014-12-19
• Last updated: 2016-02-17

Locations

1 site across 1 country: China